Trials / Completed
CompletedNCT00288041
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
A Phase II Trial of PS-341 in Combination With Paclitaxel and Carboplatin for the Treatment of Metastatic Melanoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well giving bortezomib together with paclitaxel and carboplatin works in treating patients with metastatic melanoma. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may help paclitaxel and carboplatin kill more tumor cells by making tumor cells more sensitive to these drugs
Detailed description
PRIMARY OBJECTIVE: I. Determine the confirmed tumor response rate and adverse event profile of bortezomib, carboplatin, and paclitaxel as first-line therapy for patients with metastatic melanoma. SECONDARY OBJECTIVE: I. Evaluate time to tumor progression, overall survival, and duration of response. OUTLINE: This is a multicenter study. Patients receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, and 8 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 3 years.
Conditions
- Ciliary Body and Choroid Melanoma, Medium/Large Size
- Extraocular Extension Melanoma
- Iris Melanoma
- Recurrent Intraocular Melanoma
- Recurrent Melanoma
- Stage IV Melanoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboplatin | Given IV |
| DRUG | paclitaxel | Given IV |
| DRUG | bortezomib | Given IV |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2007-09-01
- First posted
- 2006-02-07
- Last updated
- 2013-03-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00288041. Inclusion in this directory is not an endorsement.